• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 180NRE DIALYZER FINISHED ASSY. DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

OGDEN MANUFACTURING PLANT OPTIFLUX 180NRE DIALYZER FINISHED ASSY. DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number OPTIFLUX 180NRE DIALYZER FINISHED ASSY.
Device Problem Material Discolored (1170)
Patient Problem Blood Loss (2597)
Event Date 11/13/2017
Event Type  malfunction  
Manufacturer Narrative
A temporal relationship between the patient¿s episode of chest pain and the hd treatment on (b)(6) 2017 with fresenius products exists. However, there is no documentation to support a causal relationship. The patient¿s pre-existing angina (for which the patient is normally prescribed nitroglycerin) is likely related to the chest pain event. The instance of the optiflux 180 nre dialyzer and combi-set blood line clotting during hd treatment (on (b)(6) 2017) is most likely associated with inadequate anticoagulation therapy. A temporal relationship between the yellow discoloration observed in the optiflux 180 nre dialyzer and the pt¿s estimated blood loss of 250 cc (due to cessation of hd treatment per physician order) exists. However, there were no reported defects or discoloration noted with the dialyzer prior to use. There is a possible association exists between pyridium therapy (contraindicated in patients with renal insufficiency) and the observable yellow discoloration of two optiflux 180 dialyzers used for the patient¿s treatment (on (b)(6) 2017). The complaint was not confirmed by the plant. The complaint sample pass visual inspection and functional tests. The product history review indicated one approved temporary deviation notice on the alleged lot. It is unrelated to the reported complaint event. There was no indication of product non-acceptance or deviation in the manufacturing process potentially related to the complaint. This includes non-conformances, rework, labeling, process controls and any other occurrence in production. The reported lot number passed testing, was within sterilization dosage parameters and passed all release criteria.
 
Event Description
On (b)(6) 2017, this patient (pt. ) with end stage renal disease (esrd) on hemodialysis (hd) therapy began experiencing chest pain approximately 1 and ½ hours into hd treatment. The pt. Was treated with a standing order of nitroglycerin (unknown dose) which relieved the pt¿s chest pain. No further intervention was reported and the pt¿s episode of chest pain resolved. Additionally, approximately 1 hour later after the chest pain, the pt¿s extracorporeal circuit (optiflux 180 dialyzer and combi-set lines) was noted to begin clotting. The pt¿s treatment was interrupted, the pt¿s blood was re-infused and the pt. Resumed treatment with a new dialyzer and combi-set line set up. It was reported, the pt¿s heparin (anticoagulant) was held during hd treatment (on (b)(6) 2017) due to the pt¿s elevated pt/inr while on concomitant coumadin therapy for recent diagnosis of atrial fibrillation. It was reported, after the pt¿s blood was re-infused, the optiflux 180 dialyzer was observed to be yellow. Reportedly, the on-call physician ordered cessation of the pt. Treatment (after hd treatment resumed) and not to return the pt¿s blood. Subsequently, the pt. Was sent to the emergency room (er) for further evaluation of liver function and to rule out possible hemolysis. It is estimated the pt. Lost approximately 250 cubic centimeters (cc) of blood in the extracorporeal circuit (second set up). It was reported the second dialyzer used for this hd treatment was also observed to have yellow discoloration. Per the nurse manager, the pt¿s liver tests were normal and there was no evidence of hemolysis reported. The pt. Was not admitted to the hospital. Furthermore, the nurse manager reported the pt. Was being concurrently treated with the urinary tract analgesic pyridium for unspecified urinary issues. The nurse manager stated the pt. Self-reported taking pyridium on the same day as hd treatment ((b)(6) 2017). Moreover, the pt¿s nephrologist indicated the pyridium may have caused the yellow discoloration of the optiflux 180 dialyzers and noted pyridium is contraindicated in renal patients. The nurse manger also reported that a visual inspection of the dialyzers was performed prior to use and there were no observable discolorations or defects noted. The pt. Has since discontinued use of pyridium and there have been no reported further events of dialyzer discoloration during the pt¿s hd treatment.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameOPTIFLUX 180NRE DIALYZER FINISHED ASSY.
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
OGDEN MANUFACTURING PLANT
475 west 13th street
ogden UT 84404
Manufacturer (Section G)
OGDEN MANUFACTURING PLANT
475 west 13th street
ogden UT 84404
Manufacturer Contact
thomas c. johnson
920 winter st.
waltham, MA 02451
7816999499
MDR Report Key7080289
MDR Text Key94644543
Report Number1713747-2017-00382
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K002761
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 12/04/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/04/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberOPTIFLUX 180NRE DIALYZER FINISHED ASSY.
Device Catalogue Number0500318E
Device Lot Number17LU02004
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received11/13/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/06/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-